ISO-14644-1 vs. Fed 209E and other cleanrooms classification standards
Figure 1. ISO-7/Class 10k Cleanroom
ISO-14644-1 is the most well known and global cleanroom classification standard but only one of many. Other cleanroom classification standards include FED 209E, EU GMP Annex, British BS 5295, USP797/800. The FED Std 209E cleanroom classification was developed for the aerospace and electronics industry in the USA. The EU GMP cleanroom classification is for the European Community pharmaceutical and medical device industry. USP is for United States compounding pharmacies.
ISO-14644-1 is the cleanroom classification defined by the International Organization for Standardization (ISO) headquartered in Geneva Switzerland. Units are particles per meters cubed. Pharmaceutical, Medical Device, and Food companies are required by FDA to comply with GMP (Good manufacturing Practices) and CGMP (Current Good Manufacturing Practices) by maintaining controlled environment including cleanrooms. ISO-14644-1 is the most often used cleanroom standard and is also used by non-FDA regulated bodies such as semiconductor industry, hospitals, aerospace industry, laser industry, auto industry and government laboratories.
Table 2. Federal Standard 209E Cleanroom Classifications
Fed Std 209E
Fed Std 209E was defined by United States Government in 1963. It was officially discontinued in 2001 but is still used in industry. There is a close correlation between ISO-14644-1 cleanroom classes and FED Std 209E cleanroom classes. The primary difference is ISO-14644-1 lists particles per meter cubed (m3) and Fed Std 209E lists particles per feet cubed (ft3).
Grade
At Rest >0.5 um/M3
At Rest >5um/M3
Operational >0.5um/M3
Operational >5um/M3
Equivalent ISO at rest/operational
Equivalent Fed209E at rest / operational
A
3,520
20
3,520
20
ISO-5/5
100/100
B
3,520
29
352,000
2,900
ISO-5/7
100/10k
C
352,000
2,900
3,520,000
29,000
ISO-7/8
10k/100k
D
3,520,000
29,000
not defined
not defined
ISO-8/na
100k/na
Table 3. EU GMP Annex Cleanroom Classifications
EU GMP Annex European Community
EU GMP - A, B, C and D. For sterile pharmaceutical and medical device manufacturing and CGMP. It has both at rest and operational particle requirement. Issued by European Union.
Table 4. British BS 5295 Cleanroom Classifications
BS 5295 British cleanroom standard was published in 1989. It was replaced in 2019 by British version of ISO-14644-1 cleanroom classification.
Figure 2. USP797 Cleanroom Pass Thru
USP797/800 Classification
USP 797/800 is a United States standard developed by the United States Pharmacopeial Convention (USP). It is for compounding pharmacies. USP 797 focus on protection of patients by regulating sterile drug compounding. USP800 focuses on protection of workers in the compounding pharmacies dealing with hazardous drugs. USP800 cleanrooms are required to be negative pressure. USP797/800 compounding pharmacies typically are ISO-7 with ISO-5 gloves boxes or hoods and ISO-8 anterooms. They often have interlocked pass thru’s to transfer finished prescriptions to outside of cleanroom.
Summary
There are multiple cleanroom classification systems. ISO-14644-1 is the most popular and is used globally across all industries including pharmaceutical and medical device manufacturing. Fed Std 209E was a US based cleanroom classification system developed primarily for aerospace and electronics industries. EU Annex European community is for GMP sterile pharmaceutical and medical device manufacturing for European Community. USP797/800 is cleanroom classification for US based compounding pharmacies.
The author Anthony Chien has worked at American Cleanroom Systems for past 12 years. He has more than 40 years of cleanroom experience. Anthony has a BS and MS in Electrical Engineering specializing in semiconductor manufacturing from the University of Illinois. American Cleanroom Systems is a design build modular cleanroom manufacturer based in Rancho Santa Margarita CA. It is expert in ISO-5 thru ISO-8 (class 100 to class 100k) modular cleanrooms for pharmaceutical cleanrooms, medical device cleanrooms, and industrial cleanrooms.
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